Yoga in Controlling Symptoms and Reducing Stress in Women With Ovarian Cancer or Breast Cancer
RATIONALE: Yoga may improve symptoms and quality of life and reduce stress in patients with ovarian cancer or breast cancer and may help them live more comfortably.
PURPOSE: This clinical trial is studying how well yoga works in controlling symptoms and reducing stress in women with ovarian cancer or breast cancer.
Psychosocial Effects of Cancer and Its Treatment
Procedure: yoga therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Restorative Yoga for Symptom Management and Stress Reduction in Women With Ovarian Cancer|
- Fatigue as measured by the FACT-Fatigue subscale [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Psychological distress as measured by the Center for Epidemiologic Studies-Depression Scale and the State-Trait Anxiety Inventory [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Positive affect as measured by the Positive and Negative Affect Schedule [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Quality of life as measured by Functional Assessment of Cancer Therapy (FACT-O) for patients with ovarian cancer or FACT-B for patients with breast cancer [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Procedure: yoga therapy
- Determine the feasibility of implementing a restorative yoga intervention as a complementary supportive therapy for women with ovarian or breast cancer.
- Measure changes in fatigue, psychosocial distress (anxiety, depression), psychological well-being (positive emotions), and overall quality of life from baseline to completion of the study treatment.
OUTLINE: This is a pilot study.
Patients undergo a 75-minute restorative yoga session once a week for 10 weeks.
Patients complete questionnaires regarding fatigue, psychological distress (anxiety, depression), positive affect, and quality of life at baseline, immediately after the final yoga session, and then at 2 months after the final yoga session.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337233
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||Suzanne C. Danhauer, PhD||Comprehensive Cancer Center of Wake Forest University|